A randomised controlled trial to determine whether the use of indwelling pleural catheters in conjunction with talc slurry is superior to using an indwelling pleural catheter alone, in patients with malignant pleural effusion.

The efficacy of Indwelling Pleural Catheter placement versus IPC placement PLUS sclerosant (talc) in patients with malignant pleural effusions managed exclusively as out-patients - IPC-PLUS Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000599-40-GB

Enrollment

154

Registered

2012-05-28

Start date

2012-06-13

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural effusions MedDRA version: 14.1 Level: PT Classification code 10035605 Term: Pleural mesothelioma malignant advanced System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10066721 Term: Pleural effusion recurrent System Org

Interventions

Product Name: Steritalc Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Talc CAS Number: 14807-96-6 Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Symptomatic malignant pleural effusion, agreed at appropriate local / regional MDT to require IPC, defined as pleural fluid in the context of: a.Histocytologically proven pleural malignancy, OR b.Otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere, OR c.Radiologically proven pleural malignancy as diagnosed in normal clinical practice on thoracic CT in the absence of histocytological proof 2.Expected survival greater than 2 months 3.Written informed consent to trial participation. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66

Exclusion criteria

Exclusion criteria: 1. Age < 18 years. 2. Females who are pregnant or lactating. 3. Patient unable to provide informed consent. 4. Previous attempts at pleurodesis on same side as effusion requiring management. 5. Previously documented adverse reaction to talc or lidocaine. 6. Community services unable to drain indwelling pleural catheter at least twice per week. 7. Evidence of extensive lung entrapment on CXR or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis or IPC insertion. 8. Other contraindication to indwelling pleural catheter insertion 9. Patient has no access to a telephone

Design outcomes

Primary

Measure	Time frame
Main Objective: The IPC-PLUS trial is a study to help determine the best way to manage patients who develop fluid around the lung as a result of cancer (malignant pleural effusion). The aim is to compare outcomes in two groups of patients. The first group will be treated with an indwelling pleural catheter (IPC, or tunnelled chest tube) to help drain away the fluid, and will then be given an inert placebo substance (saline) into the drain before being followed up. The second group will receive the same type of IPC to drain away the fluid, but will then be given an injection of sterile talc powder into the drain instead of placebo. Our primary objective is to determine whether introducing talc through the IPC leads to an improved rate of successful pleurodesis, whereby the two linings of the lung are stuck together to prevent further fluid build-up. This is a randomised controlled trial, which means patients will be randomly allocated to receive either the placebo injection or the talc injection;Secondary Objective: We shall be evaluating the impact of combining an IPC and talc on patients' symptoms, specifically local pain and breathlessness. This will be done using validated visual-analogue assessments, which involves simply putting a mark on a line. We are also monitoring patients' subjective quality of life scores using serial questionnaires. Patients will undergo regular follow-up in order to determine if there are any significant medical complications to combining these two treatments. At these visits, patients will also have a thoracic ultrasound scan to determine whether the fluid is becoming contained in separate pockets, or 'loculated,' as this can affect the ease with which drainage occurs.;Primary end point(s): The primary outcome measure is the proportion of patients who achieve successful pleurodesis within 5 weeks of randomisation Pleurodesis is defined as the collection of less than or equal to 20mls of fluid on three consectutive occasions from	—

Measure

Time frame

Main Objective: The IPC-PLUS trial is a study to help determine the best way to manage patients who develop fluid around the lung as a result of cancer (malignant pleural effusion). The aim is to compare outcomes in two groups of patients. The first group will be treated with an indwelling pleural catheter (IPC, or tunnelled chest tube) to help drain away the fluid, and will then be given an inert placebo substance (saline) into the drain before being followed up. The second group will receive the same type of IPC to drain away the fluid, but will then be given an injection of sterile talc powder into the drain instead of placebo. Our primary objective is to determine whether introducing talc through the IPC leads to an improved rate of successful pleurodesis, whereby the two linings of the lung are stuck together to prevent further fluid build-up. This is a randomised controlled trial, which means patients will be randomly allocated to receive either the placebo injection or the talc injection;Secondary Objective: We shall be evaluating the impact of combining an IPC and talc on patients' symptoms, specifically local pain and breathlessness. This will be done using validated visual-analogue assessments, which involves simply putting a mark on a line. We are also monitoring patients' subjective quality of life scores using serial questionnaires. Patients will undergo regular follow-up in order to determine if there are any significant medical complications to combining these two treatments. At these visits, patients will also have a thoracic ultrasound scan to determine whether the fluid is becoming contained in separate pockets, or 'loculated,' as this can affect the ease with which drainage occurs.;Primary end point(s): The primary outcome measure is the proportion of patients who achieve successful pleurodesis within 5 weeks of randomisation Pleurodesis is defined as the collection of less than or equal to 20mls of fluid on three consectutive occasions from

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Self-reported quality of life status, measured at 14, 28, 42, 56, and 70 days, using the EQ-5D health questionnaire 2. Self-reported VAS scores, measured daily from randomisation to 10 weeks post-randomisation, for a. Thoracic pain b. Breathlessness 3. Total volume of pleural fluid drained from randomisation to 10 weeks post-randomisation 4. All-cause mortality up to 10 weeks post randomisation. 5. Number of hospital inpatient bed-days required from randomisation to 10 weeks post-randomisation 6. Degree of loculation of pleural fluid following talc instillation as judged by thoracic ultrasound and septation score at two-weekly intervals for 10 follow-up period 7. Pleurodesis success at 10 weeks post randomisation 8. Time from randomisation to successful pleurodesis, up to 10 weeks;Timepoint(s) of evaluation of this end point: See above	—

Measure

Time frame

Secondary end point(s): 1. Self-reported quality of life status, measured at 14, 28, 42, 56, and 70 days, using the EQ-5D health questionnaire 2. Self-reported VAS scores, measured daily from randomisation to 10 weeks post-randomisation, for a. Thoracic pain b. Breathlessness 3. Total volume of pleural fluid drained from randomisation to 10 weeks post-randomisation 4. All-cause mortality up to 10 weeks post randomisation. 5. Number of hospital inpatient bed-days required from randomisation to 10 weeks post-randomisation 6. Degree of loculation of pleural fluid following talc instillation as judged by thoracic ultrasound and septation score at two-weekly intervals for 10 follow-up period 7. Pleurodesis success at 10 weeks post randomisation 8. Time from randomisation to successful pleurodesis, up to 10 weeks;Timepoint(s) of evaluation of this end point: See above

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026